Inherited Diabetes Testby Admera Health

Some people with diabetes have a rare, inherited form that can be misdiagnosed. That can impact how effectively the diabetes is treated. Better understand your diabetes diagnosis by learning if you have MODY.

Discover if you have a genetic variant known to cause Maturity Onset of Diabetes of the Young.

Inherited Diabetes Test

$149.99

Helix DNA kit

$80.00

Required one time only so Helix can collect a saliva sample from you and sequence your DNA.

To use this product, you must be 18 or older and be a U.S. resident. Not available for residents of New York, New Jersey, or Rhode Island.

Clarify your diabetes diagnosis

Clarify your diabetes diagnosis

Most people with diabetes have Type 1 or Type 2, but 1-5%1 of people with diabetes have a rare, inherited form called MODY and don’t even know it. Finding out if you have MODY can help you and your doctor better manage your disease.

Most people with diabetes have Type 1 or Type 2, but 1-5%1 of people with diabetes have a rare, inherited form called MODY and don’t even know it. Finding out if you have MODY can help you and your doctor better manage your disease.

Inherited Diabetes Test

by Admera Health

What is inherited diabetes?

Type 1 and Type 2 Diabetes are known to be caused by a complex combination of environmental, lifestyle and genetic factors, where many genetic variations add up to play a small role in developing the disease. One form of inherited diabetes, also known as Maturity Onset Diabetes of the Young (MODY), is different. With MODY, a single genetic variation can cause the disease. While MODY is often diagnosed in childhood or adolescence, despite the name, it can be diagnosed at any age.

Why learn about MODY?

People with MODY may respond best to different therapies than people with other types of diabetes. Type 1 Diabetes is treated with insulin, and Type 2 Diabetes is treated with lifestyle modifications, oral medications, and sometimes insulin. For some people with MODY, insulin may not be an effective treatment. By knowing if you have MODY, you and your doctor can make sure you’re managing your diabetes most effectively.

Because this type of diabetes is inherited, it can also be important information for relatives who may have or might be at risk for MODY.

Who is at risk for having inherited diabetes?

If your diabetes was diagnosed at a young age (often under age 25), you are not overweight, and you have a first degree relative with diabetes (such as a parent, sibling, or child), you may want to learn if you have MODY. While most people diagnosed with MODY are young, it can be diagnosed at any age.

If someone is found to have a genetic variation that causes inherited diabetes, there is a 50% (or a 1 out of 2) chance that their first degree relatives will have it too. This means that their parents, siblings, and children all have a 1 in 2 chance of inheriting the same variation and at some point developing MODY.

Why haven’t I heard of inherited diabetes?

Up to 500,000 people in the United States are estimated to have MODY2, but because genetic testing for inherited diabetes is relatively new, many are unaware. That means that about 9 out of 10 people with MODY could potentially get more personalized treatment by knowing if they have MODY.

What will my results tell me?

This product generates two possible results:

No variant found: No variants linked to MODY were found.

Pathogenic: Likely pathogenic and pathogenic variants have very strong and definitive scientific evidence linking them with disease respectively. You should talk with your doctor or an endocrinologist, a specialist in diabetes, about managing your diabetes differently based on the results of this test. Consulting with a genetic counselor may also be helpful.

The science

Through years of research, scientists studied families with many members who had early-onset diabetes. This research led to the discovery that some forms of diabetes are strongly heritable, and researchers were then able to identify gene variants that play a part in the development of diabetes. Now, we know that if someone has one of these heritable gene variants, they have a high risk of developing diabetes. We can also use genetic testing to make sure that people diagnosed with diabetes get the right treatment for their form of diabetes.

Impact

While most cases of diabetes are caused by a combination of genetic, environmental, and lifestyle factors, MODY is caused mostly by your genetics.

Limitations

This product does not identify all possible genes or gene variants associated with MODY.

This product does not provide risk score calculations for diabetes.

This product does not check genes associated with type 2 diabetes.

This product does not look at the genes associated with the most common form of type 1 diabetes.

Our understanding and interpretation of gene variants will develop as the science evolves.

Results from this product are not intended to be used without consultation by a healthcare provider.

How it works

Because this test screens for conditions that might have serious medical implications, Admera Health provides a physician to review your health history to ensure it’s right for you before testing.

No paperwork

Answer a few questions about your health history when placing your order online. It takes just a few minutes.

No additional cost

The review of your health history adds no additional cost to your test, and insurance isn’t required.

Order and provide your health history

Physician reviews your information

Helix sends a DNA kit to your home

Provide a saliva sample and get sequenced

Get an email when your results are ready

The Helix DNA kit

To capture the information stored in your DNA so it can be used for this product, we need to collect a small, one-time saliva sample from you. This kit has everything you need to provide that sample from the comfort of your own home, and you’ll never have to provide another.

A unique Kit ID you’ll use to register your kit

Saliva collection tube, cap, and printed instructions

A small bag and prepaid box to send your saliva sample to our lab

The Helix DNA kit

To capture the information stored in your DNA so it can be used for this product, we need to collect a small, one-time saliva sample from you. This kit has everything you need to provide that sample from the comfort of your own home, and you’ll never have to provide another.

A unique Kit ID you’ll use to register your kit

Questions

What genes does this product check?

Inherited Diabetes Test looks at more than 300 gene variants that have been shown in the previous studies to be associated with MODY. The genes checked in this test are ABCC8, BLK, CEL, GCK, HNF1A, HNF4A, INS, KCNJ11, KLF11, NEUROD1, PAX4, PDX1, and TCF2. However, it does not check all possible gene variants linked to MODY that account for a small number of cases.

Does this product check for variants of unknown significance (VUSs)?

We all have unique variations in our DNA, and some are well known but many are just being discovered. There may be variants found in your DNA that haven’t yet been categorized. Some may be responsible for the condition, while others may just be a normal version of the gene that scientists simply haven’t seen before. We refer to these as “variants of unknown significance,” or VUSs. For these products, VUSs are not reported since we do not have enough evidence to know which will increase risk for MODY. As our understanding of VUSs improves over time, this product may become more comprehensive as we learn which VUSs do and do not increase risk for MODY.

Can I choose my own physician to approve testing?

No. When you order the Inherited Diabetes Test, you answer relevant health history questions. Helix will share your contact information and health history with Admera Health so a physician from an independent provider network can review and make sure this product is right for you. This process helps make sure you get access to these insights quickly and efficiently through a provider that is familiar with this type of testing. You can always share your results with your healthcare providers.

Do I need access to my medical records to answer the health history questions?

While it might help to have your records handy, it’s definitely not required. It’s okay to answer the health history questions from memory to the best of your ability.

Can I use my health insurance benefits to purchase this product?

Unfortunately, no. This is an at-home test that doesn’t require an office visit, and we cannot currently accept payment from insurance providers.

Will someone be available to help me understand my results?

While your results will be delivered to you in an easy-to-understand format, Admera Health knows that you may have questions. That’s why Admera Health makes available, through an independent provider network, genetic counselors who can help you understand what your results mean for you and your family. We also encourage you to share your results with your physician if you have any specific questions or concerns.

Do I have to get sequenced to use this product?

Yes. In order to use the Inherited Diabetes Test, you need to be sequenced by Helix. To ensure the quality and accuracy of the genetic information used for this service, products in the Helix marketplace do not accept genetic data from outside sources.

How does Helix provide my DNA information to Admera Health? Is it shared with anyone else?

Your DNA information is stored securely by Helix. When sequencing is complete, Helix only sends the relevant DNA information needed by Admera Health to generate your results. We do not share your DNA information with anyone without your permission. We always maintain high standards when it comes to the security and privacy of your DNA information.

How do I learn more about how Admera Health uses my information?

How do I view my results?

Admera Health will send you an email when your results are ready to be viewed online.

References

1

National Institute of Diabetes and Digestive and Kidney Diseases. “Monogenic Forms of Diabetes.” Accessed July 22, 2017. www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/monogenic-neonatal-mellitus-mody.

2

Center for Disease Control and Prevention. “2014 National Diabetes Statistics Report.” Accessed July 22, 2017. www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html.

About Admera Health

Admera Health is a CLIA-certified and CAP-accredited advanced molecular diagnostics company focused on personalized medicine and digital health. It’s Admera Health’s mission to deliver transformative, valuable solutions for patients, physicians, and clinical researchers. Admera Health is committed to improving the health and well-being of the global community through the direct delivery of personalized, medically actionable results.

About Helix

Helix empowers everyone to explore what makes them unique—their DNA.

From health and wellness insights to family planning and ancestry information, Helix’s growing list of partners can tap into your genetic profile to provide relevant insights for today, tomorrow and years to come.

Why do I need the Helix DNA kit?

Products on Helix use the DNA information found in your saliva to give you insights into what makes you, you. The Helix DNA kit has everything you need to provide a saliva sample and send it to our lab so we can sequence your DNA.

Once you’re sequenced, you can gain insights from any product on Helix for years to come—all without having to provide another saliva sample ever again.